IMPORTANT SAFETY INFORMATION ON STRATTERA FOR CHILDREN AGED 6 AND OLDER, ADOLESCENTS AND ADULTS
Suicidal Ideation in Children and Adolescents
Strattera® (atomoxetine HCl) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of Strattera in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and timely communication with the prescriber if changes in thoughts or behaviors occur. Strattera is not approved for major depressive disorder.
Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of Strattera in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving Strattera compared to placebo. The average risk of suicidal ideation in patients receiving Strattera was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials.
- All pediatric patients being treated with Strattera should be monitored closely for suicidality, clinical worsening, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients who are experiencing emergent suicidality or symptoms that might be precursors to emerging suicidality, especially if these symptoms are severe or abrupt in onset, or were not part of the patient's presenting symptoms. A similar analysis in adult patients treated with Strattera for either ADHD or major depressive disorder (MDD) did not reveal an increased risk of suicidal ideation or behavior in association with the use of Strattera.
- Strattera should not be taken by patients: with narrow angle glaucoma; patients who are taking or have taken an MAOI within 2 weeks of starting Strattera; or patients who have hypersensitivity to atomoxetine or other constituents of product.
- Postmarketing reports indicate that Strattera can cause severe liver injury in rare cases; although no evidence of liver injury was detected in clinical trials of about 6000 patients. Strattera should be discontinued in patients with jaundice or laboratory evidence of liver injury, and should not be restarted. Laboratory testing to determine liver enzyme levels should be done upon the first symptom or sign of liver dysfunction.
- Sudden death, stroke and myocardial infarction have been reported in association with atomoxetine treatment. Patients should have a careful history and physical exam to assess for presence of cardiovascular disease. Strattera should not be used in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac abnormalities.
- Strattera should be used with caution in patients with hypertension, hypotension, tachycardia, or cardiovascular or cerebrovascular disease because it can increase blood pressure and heart rate. Pulse and blood pressure should be measured at baseline, following Strattera dose increases, and periodically while on therapy. Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during atomoxetine treatment should undergo a prompt cardiac evaluation.
- In general, particular care should be taken in treating ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in patients at risk for bipolar disorder. Prior to initiating treatment with Strattera, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
- Treatment-emergent psychotic or manic symptoms in children and adolescents can be caused by Strattera. Consideration should be given to a possible causal role of Strattera. Discontinuation of treatment may be appropriate.
- Rare postmarketing cases of priapism have been reported in pediatric and adult patients treated with Strattera. Prompt medical attention is advised in the event of suspected priapism.
- Patients beginning treatment for ADHD should be monitored for the appearance or worsening of aggressive behavior or hostility. Aggressive behavior or hostility is often observed in children and adolescents with ADHD. Although this is not conclusive evidence that Strattera causes aggressive behavior or hostility, these behaviors were more frequently observed in clinical trials among children and adolescents treated with Strattera compared to placebo (overall risk ratio of 1.33 [95% C.I. 0.67-2.64 - not statistically significant]).
- Although uncommon, allergic reactions, including angioneurotic edema, urticaria, and rash, have been reported with Strattera.
- Complaints of urinary retention or urinary hesitancy should be considered potentially related to Strattera.
- Strattera is considered Pregnancy Category C: Patients should be instructed to consult a physician if they are nursing, pregnant, or thinking of becoming pregnant while taking Strattera.
- As with all ADHD medications, growth should be monitored during treatment, although height and weight data measured up to 3 years indicates minimal, if any, long-term effects.
- In children and adolescents, the most common adverse events reported in clinical trials were decreased appetite, nausea, vomiting, fatigue, dyspepsia, and somnolence.* In adults, the most common adverse events reported in clinical trials were dry mouth, insomnia, nausea, appetite decrease, constipation, erectile disturbance, dysmenorrhea, dizziness, and libido decrease.*
*In clinical trials, adverse events reported in at least 5% of patients and twice the rate of placebo
